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On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animaltesting in drugdevelopment, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. 7] This was a landmark change in philosophy.
While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drugdevelopment is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I).
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drugdevelopment due to their close genetic, anatomical and physiological resemblance to humans. References Animal Legal Defense Fund v. Federal ruling on USDA primate welfare petition, 2023. USDA (2020).
The current landscape of protein drugdevelopment is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.
CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.
Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drugdevelopment pipeline. The two broadest categories of drugdevelopment can be separated into the preclinical and clinical research stages. over this period.
In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drugdevelopment. 1975 Aug;256(5517):495–7. Antibodies to watch in 2024.
President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars.
The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animaltesting. Nonclinical studies encompass much more than just animal studies.
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